Quality Assurance Operations Supervisor 2nd Shift

Petersburg, VA
November 16, 2024

Apply for this job

Email *
Phone Number *
City *
State *
Browse

Upload file .pdf, .doc, .docx

Job Description

About Civica:

In the last 20 years, the U.S. has faced a significant rise in shortages of essential generic injectable medications, with over 300 reported shortages. This crisis stems from “race to the bottom” pricing, manufacturing challenges, and predatory pricing, ultimately impacting patients the most.

Civica, a 501(c)(4) social welfare organization founded in 2018 by various health systems and philanthropies, aims to combat these shortages and high prices. With over 55 health systems representing 1,500 hospitals, Civica also supplies essential medicines to the U.S. Department of Veterans Affairs and the Department of Defense. Their guiding principle is to prioritize patient interests.

Recently, Civica has expanded its mission to include affordable biosimilar insulin, ensuring consistent availability for those in need. Learn more at www.civicarx.org.

Job Description

The Quality Assurance Operations Supervisor at Civica’s Petersburg, Virginia site will ensure compliance with regulatory standards in the manufacturing of essential generic sterile injectable medications.

Essential Duties and Responsibilities:

  • Oversee quality systems for manufacturing and packaging operations.
  • Conduct real-time batch record reviews and manage deviations.
  • Promote a culture of quality and safety.
  • Ensure compliance with FDA and DEA regulations.
  • Develop and maintain Standard Operating Procedures (SOPs).
  • Lead training and development for team members.
  • Support process transfers and quality systems across the product lifecycle.
  • Participate in quality risk analysis and problem resolution.

Basic Qualifications:

  • Bachelor’s degree in a scientific discipline with 6+ years of Quality/CGMP experience.
  • Experience in sterile injectable manufacturing.
  • Strong project management and supervisory skills.
  • Excellent communication skills and proficiency in software applications.
  • Self-motivated and adaptable in a fast-paced environment.

Preferred Qualifications:

  • Technical expertise in sterile pharmaceutical isolator technology.
  • Experience with DEA regulations for controlled substances.